MAUDE Adverse Event Report: DATASCOPE CORP. CS100 INTRA-AORTIC BALLOON PUMP, REFURBISHED, JAPANESE,NON-UTS,DOM; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Model Number	0998-UC-3013-65
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/11/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1 city : (b)(6).A supplemental report will be submitted upon completion of our investigation.
Event or Problem Description
It was reported that during regular inspection, the cs100 intra-aortic balloon pump (iabp) has caster damage.There was patient involvement.
Event or Problem Description
It was reported that during regular inspection, the cs100 intra-aortic balloon pump (iabp) has caster damage.There was no patient involvement.
Additional Manufacturer Narrative
Updated fields - b4,d9,g3,g6,h2,h3,h6(type of investigation,investigation findings,component code,investigation conclusions,h10,h11.Corrected fields - d4(catalog #).A getinge field service engineer (fse) confirmed caster damage.Operating time: 8,887 hours.Replaced due to damage on the front of the caster.Device passed all functional tests.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
**udi related data quality updates only** providing updated device identification information in alignment with gudid (d1, d2, d3, d4, g4, h4, h5).
Additional Manufacturer Narrative
A getinge field service engineer (fse) evaluated the unit for the reported malfunction.The fse replaced the caster (0401-00-0062).The driving test had good results.Functionality and safety checks were completed.The iabp was returned to the customer.The defective components were received for further investigation.

• Brand Name: CS100 INTRA-AORTIC BALLOON PUMP, REFURBISHED, JAPANESE,NON-UTS,DOM
• Common Device Name: SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
• Manufacturer (Section D): DATASCOPE CORP.; 1300 macarthur blvd; mahwah NJ 07430
• Manufacturer (Section G): DATASCOPE CORP.; 1300 macarthur blvd; mahwah NJ 07430
• Manufacturer Contact: henry pena ; 1300 macarthur blvd; mahwah, NJ 07430
• MDR Report Key: 18551976
• Report Number: 2249723-2024-00279
• Device Sequence Number: 6402324
• Product Code: DSP
• UDI-Device Identifier: 10607567108674
• UDI-Public: (01)10607567108674(21)SA02595-E4
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K031636
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 01/21/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 0998-UC-3013-65
• Device Catalogue Number: 0998-UC-3013-65
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/11/2024
• Supplement Date Received by Manufacturer: 03/18/2024; 05/08/2024; 11/28/2024; 01/03/2025
• Initial Report FDA Received Date: 01/22/2024
• Supplement Report FDA Received Date: 03/18/2024; 05/16/2024; 12/06/2024; 01/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown